Scalp cooling apparatus, method, and system

ABSTRACT

A scalp cooling apparatus, method, and system that may include an inner scalp cap, an intermediate scalp covering, and an outer scalp cap. The inner scalp cap may be fluidly coupled to a cooling device, that would allow a cooling fluid to traverse the fluid chambers within a set of sections of the inner scalp cap. The inner scalp covering can be constructed of a thermally conductive material. The intermediate scalp covering can be constructed of a thermally neutral material. The outer scalp covering can be constructed of a thermally resistant material. The outer scalp covering may have a first securing mechanism, and a second securing mechanism, that allow the outer scalp covering to be dynamically adjusted and secured against a patient&#39;s scalp via the first securing mechanism and the second securing mechanism. The inner scalp cap may be created from a scan of a patient&#39;s head, that can then be utilized as an interpolated parametric model may be utilized to generate an output file.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/758,080, filed Nov. 9, 2018, of which is incorporated herein byreference in its entirety.

BACKGROUND Technical Field

The present disclosure relates to biological cooling. More particularly,and not by way of limitation, the present disclosure is directed to anapparatus, system, and method for cooling of a scalp.

Description of Related Art

During chemotherapy or other cancer treatments, a patient's hair willtypically fall out due to the various treatments and chemicals utilizedto battle the cancer cells. However, it has also been discovered thatwhen the scalp is cooled during these treatments the amount of hair lossis reduced. The reduced temperatures result in a reduced blood flow tothe scalp area so that less chemotherapy reaches the hair cells.

Dignitana AB has been a leader in the development of hair losstreatments for cancer patients, and has filed a number of patentapplications covering head cooling devices including U.S. Pat. Nos.9,421,125, 9,101,463, and PCT/EP2008/051890; a scalp cooling apparatusU.S. Pat. No. 6,156,059; and methods and devices for controlling thetemperature of local regions of a patient's body U.S. application Ser.No. 12/086,060, and PCT/SE2006/001383. These patents and applicationsare incorporated herein by reference.

Current systems allow for a one size fits all silicon cap, thermal cap,and an outer cap to be utilized, that can result in unreliable fitand/or the possibility of infections or other viruses. It would beadvantageous to have an apparatus, system, and method for cooling of ascalp that overcomes the disadvantages of the prior art. The presentdisclosure provides such a system and method.

BRIEF SUMMARY

The present disclosure is directed to the cooling of a human scalp.Thus, in one aspect, the present disclosure is directed to an apparatusfor a scalp covering that may include a linking section having a firstend and a second end. A forward central section is coupledperpendicularly to the linking section at a first end. A rearwardcentral section is coupled perpendicularly to the linking section at afirst end. A first set of forward radial sections is coupled to thelinking section, a second set of forward radial sections is coupled tothe linking section, a first set of rearward radial sections is coupledto the linking section, and a second set of rearward radial sections iscoupled to the linking section.

In another aspect, the present disclosure is directed to a system forscalp covering including an inner scalp covering, an intermediate scalpcovering, and an outer scalp covering. The inner scalp covering can beconstructed of a thermally conductive material. The intermediate scalpcovering can be constructed of a thermally neutral material. The outerscalp covering can be constructed of a thermally resistant material. Theinner scalp covering may be coupled via fluid channels to a coolingdevice, and the cooling device fluidly coupled to a set of sections ofthe inner scalp covering for interfacing with a patient's scalp. Theouter scalp covering may include a first securing mechanism, and asecond securing mechanism, that allow the outer scalp covering to bedynamically adjusted and secured against a patient's scalp via the firstsecuring mechanism and the second securing mechanism.

In yet another aspect, the present disclosure is directed to a method ofmanufacture for a scalp covering including scanning a patient's scalp togenerate a scan data set, importing the scan data set, creating aparametric model from the scan data set, interpolating the parametricmodel, remapping the parametric model, generating a design file from theremapped parametric model, and outputting the design file. The scanningmay be completed utilizing a three-dimensional scanner. The creation ofthe parametric model can also include calculating a centroid point ofthe patient's ear, calculating an azimuthal angle of the patient'sforehead hairline, and calculating an azimuthal angle of the patient'snape hairline. Interpolation can include calculating a head radius, andcalculating a head surface. The generated design file can includecalculations for the width of a section of the scalp covering, theradial angles for a section of the scalp covering, and calculating thenumber of sections for the scalp covering.

In yet another aspect, the present disclosure is directed to a method ofuse for a scalp covering system including, placing an inner scalpcovering over a patient's scalp, covering the inner scalp covering withan intermediate scalp covering, interfacing an outer scalp covering withthe intermediate scalp covering and the inner scalp covering, andsecuring the outer scalp covering to the patient's scalp utilizing atleast two securing mechanisms coupled to the outer scalp covering. Theinner scalp may be fluidly coupled to a cooling device via channels inthe inner scalp covering. The tightening of the inner scalp covering canalso tighten the intermediate scalp covering via hook and loop straps ofa connecting strap with a first side and a second side of the outerscalp covering. The tightening can also be competed through a buckle ata first end of the connecting strap, or a second end of the connectingstrap. The outer scalp covering may have at least two securingmechanisms to tighten a securing cable coupled to each of the at leasttwo securing mechanisms or release the two securing mechanisms.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features believed characteristic of the disclosure are setforth in the appended claims. The disclosure itself, however, as well asa preferred mode of use, further objectives and advantages thereof, willbe best understood by reference to the following detailed description ofillustrative embodiments when read in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is an illustration of a patient with a scalp cap that can beutilized with a cooling system.

FIG. 2 is an illustration of a patient with a thermal cap that can beutilized with a cooling system.

FIG. 3A is an illustration of the application of a securing cap to apatient for utilization with a cooling system.

FIG. 3B is an illustration of the application of a securing cap forutilization with a cooling system.

FIG. 4A is an illustration of a securing cap from a perspective view.

FIG. 4B is an illustration of a securing cap from a side view.

FIG. 5A is a perspective view illustration of a scanned head for aparametric processing.

FIG. 5B is a side illustration of a scanned head for a parametricprocessing.

FIG. 6 is a side view illustration of a scanned head, for parametricprocessing.

FIG. 7 is a side view illustration of a scanned head, for parametricprocessing.

FIG. 8 is an illustration of a scanned head, for parametric processing.

FIG. 9A is an illustration of a design file output from a parametricprocessing.

FIG. 9B is an illustration of a design file output from a parametricprocessing, placed on the head of a patient.

FIG. 9C is an illustration of a scalp cap as generated from theparametric processing.

FIG. 10 is an illustration of an alternative design output from aparametric process.

FIG. 11 is an illustration of a cooling system.

FIG. 12 is an illustration of a method of manufacture for a scalpcovering.

FIG. 13 is an illustration of a method of use for a scalp coveringsystem.

DETAILED DESCRIPTION

FIG. 1 is an illustration of a patient 102 with a scalp cap 104 utilizedwith a cooling system. The scalp cap 104 can be a silicon or othermaterial that is thermally conductive but is a single piece of materialwith no cuts or trimming lines. The scalp cap 104 would not allow for acomplete fit due to the nature of the material not conforming with apatient's scalp. The shape of a patient's scalp can present issues whenthe scalp cap 104 is constructed based on a one size fits all model. Toprovide effective cooling the scalp cap 104 must maintain a maximumcontact with the patient's scalp, which is impossible to do with genericor a fixed set of scalp cap 104 versions as each patient 102 has aunique scalp profile. Using prior designs, the temperature differencesbetween the scalp and the scalp cap 104 could be more than eighteen (18)degrees centigrade.

FIG. 2 is an illustration of a patient 202 with a thermal cap 206 (orintermediate covering) to be utilized with a cooling system in at leastone embodiment. The thermal cap 206 can be constructed of a thermallyresistant or thermally reflective material such as cotton, ceramic,fiberglass, aluminized, silicone, silica, aramid, vermiculite, Z-block,acrylic, PTFE fabrics or infused fabrics. In at least one embodiment,the thermal cap 206 is made of cotton or other fabrics. A patient 202can use the thermal cap 206 to prevent or reduce the amount of coolinglost to a room. For example, the thermal cap 206 may be utilized toincrease the cooling effect of the cooling system and the scalp cap (notillustrated).

FIG. 3A is an illustration of a patient 302 applying a securing cap 308(or outer scalp covering) over a thermal cap (not illustrated) and/orscalp cap (not illustrated) for utilization with a cooling system. Thesecuring cap 308 can include at least one securing mechanism 310 toincrease pressure on the thermal cap (not illustrated) and/or the scalpcap (not illustrated). The at least one securing mechanism 310 canutilize a securing line 311 that can be tightened or released by the atleast one securing mechanism. In some embodiments, the at least onesecuring mechanism 310 can be pressed in or clicked in, and rotated totighten the securing line 311, and the at least one securing mechanism310 can be pulled out or clicked out, to loosen the securing line 311.In other embodiments, the at least one securing mechanism 310 can bepulled out or clicked out, and rotated to tighten the securing line 311,and the at least one securing mechanism 310 can be pressed in or clickedin, to loosen the securing line 311. In at least one example, thesecuring cap 308 applies a pressure or securing pressure to the thermalcap (not illustrated) and also the scalp cap (not illustrated) to ensurethat a scalp cap is as close to the scalp and/or maintains as muchcontact as possible to increase the amount of cooling for the patient'sscalp and/or hairline.

FIG. 3B is an illustration of a patient 302 securing a securing cap 308(or outer covering) over a thermal cap (not illustrated) and/or scalpcap (not illustrated) for utilization with a cooling system. In at leastone version, the securing cap 308 can include a plurality of securingmechanisms 310. The securing mechanism(s) 310 can provide for anengagement or disengagement of the securing mechanism by the patient 302that can include a tightening or loosening of the securing cap 308against the thermal cap (not illustrated) and/or scalp cap (notillustrated). The at least one securing mechanism 310 can utilize asecuring line 311 that can be tightened or released by the at least onesecuring mechanism. In some embodiments, the at least one securingmechanism 310 can have a knob that may be pressed in or clicked in, androtated to tighten the securing line 311, and the at least one securingmechanism 310 can have a knob that may be pulled out or clicked out, toloosen the securing line 311. In other embodiments, the at least onesecuring mechanism 310 can have a knob that may be pulled out or clickedout, and rotated to tighten the securing line 311, and the at least onesecuring mechanism 310 can have a knob that may be pressed in or clickedin, to loosen the securing line 311. In some embodiments, the securingcap 308 can have a chin strap 301 or a connecting strap. The chin strap301 may have a buckle 303 or other fastening mechanism such as, but notlimited to, a button, clip, strap, or hook and loop fasteningmechanisms.

FIG. 4A is an illustration of a securing cap 408 from a perspectiveview. FIG. 4B is an illustration of a securing cap 408 from a side view.With respect to FIGS. 4A and 4B, a patient 402 can place the securingcap 408 on the head for use in securing and/or applying pressure toother caps beneath the securing cap 408. In at least one version thesecuring cap 408 can include at least two securing mechanism(s) 410. Theat least two securing mechanism(s) 410 can be placed on a left side 403Aand a right side 403A of a patient's head. The securing mechanism(s) 410may be placed on a securing pad 412. The securing pad 412 can providefor a shifting of the securing mechanism(s) 410 as they are engaged ordisengaged. The shifting accounts for variations in the head profile orsize of a patient 402, allowing for the securing cap 408 and/or securingmechanism(s) 410 to provide a securing and comfortable fit. The securingmechanism(s) 410 in at least one example can be BOA® brand ratchetingmechanisms.

The securing mechanism(s) 410 can each have a securing line 414 passedthrough securing loop(s) 416A, 416B, 416C, 416D, and/or 416E(collectively 416). The securing loops(s) 416 can be coupled throughthread, fastener such as, but not limited to hook and loop, glues,adhesives, or other similar or like methods of attachment and/orcoupling to the securing cap 408. There may be additional or fewersecuring loops(s) 416 based on the size and/or position of the securingmechanism(s) 410 in respect to the securing cap 408. In at least oneversion of the securing cap 408, a strap securer 418 and/or a chin strap420 may also be utilized to increase the securability of the securingcap 408. The strap securing 418 and/or the chin strap 420 may allow foradjustability of the securing cap 408 under and/or around the chin orface of a patient.

FIG. 5A is a perspective view illustration of a scanned head 522 usedfor a parametric processing 500A. In at least one version of theparametric processing 500A, at least one axis is provided. The axis(s)524A, 524B, and/or 524C provide a reference for the dimensions of apatient's head as scanned. The scanning can be performed utilizing a 3Dscanner, images of the patient, X-rays, CAT scans, MIR imaging, or othermethods of imaging and/or measuring.

FIG. 5B is a side illustration of a scanned head 522 for a parametricprocessing 500B. In at least one version of the parametric processing500B, at least one axis is provided. The axis(s) 524D, and/or 524Eprovide a reference for the dimensions of a patient's head as scanned. Aparametric model may be developed from the scanned head 522. During thedevelopment of the parametric model, a user may rotate or change theviewing angle of the scanned head 522 to allow for different details tobe seen or analyzed. With respect to FIGS. 5A and 5B, a process can beutilized to convert an image, set of images, or imaging output forutilization with a processing program that allows for the creation of apersonalized scalp cap (not illustrated). For example, the data may bein one format such as, but not limited to, comma separated values (CSV),or an excel format XSL or XSLX, or other data format for specificprograms or systems such as a 3D or three-dimensional scanner. If dataprovided from the scanning is in a format that is unusable then it wouldbe necessary to utilize a program that can convert, or transform thedata into a usable format. Any computer, processor, or computing devicemay be utilized to generate, create, process, and/or develop theparametric model.

FIG. 6 is a side view illustration of a scanned head 622, for parametricprocessing 600. In at least one version, the parametric processing 600can include establishing the hair line of a scanned head 622 and caninclude the nape line 628A and the brow line 628B (collectively 628) ofa personalized scalp cap (not illustrated). Some of the additionalfactors to consider are generating an ear cutout 630 to allow for thescalp cap (not illustrated) to rest tight against and/or behind the ear626 of a patient. The nape line 628A and the brow line 628B, along withthe ear cutout 630 may be calculated and/or generated by a computingdevice, processor, or program. In some examples, one or more of the napeline 628A, brow line 628B, or ear cutout 630 may be selected manually,and the remainder calculated and/or generated by a computing device,processor, or program. In at least one embodiment, the nape line 628A,brow line 628B, and ear cutout 630 are automatically determined and/orcalculated by a computing device, processor, or program based on thedata provided during the scanning or parametric processing steps. Agraphical user interface (GUI) may be utilized to illustrate thedetermination and/or calculation performed by a computing device,processor, or program. In the event that the determination and/orcalculation is incorrect due to an issue with the data provided to thecomputing device, processor, or program, or from an unusual scalp orhead profile, the GUI, and/or computing device, processor, or program,can allow a doctor or user to select one or more of the nape line 628A,brow line 628B, and/or ear cutout 630 to manually adjust or reset theline(s). If a line has been adjusted and/or reset then all the remaininglines may be determined and/or calculated again by the computing device,processor, or program.

FIG. 7 is a side view illustration of a scanned head 722, for parametricprocessing 700. After the generation of the hair line 728 and the earcutout 730 around and/or behind the ear 726, a polar grid 732 can begenerated. The polar grid 732 allows for longitudinal lines 734A, 734B,734C (collectively 734) and latitudinal lines 736A, 736B, 736C(collectively 736). The longitudinal lines 734 and the latitudinal lines736 allow for the conversion to polar coordinates from parametricprocessing and incorporation of any changes and/or differences of thescanned head 722. Polar coordinates also allow for a parametric modelthat follows the curvature of a human head. In at least one version, theparametric processing 700 generates a parametric model that sets thelongitudinal lines 734 at fixed angles from a centroid point 735, andthe latitudinal lines are set at fixed distances 733 from each otherstarting from a centroid point 735. The centroid point 735, in at leastone example can be the center of the ear 726. While in other examples,the centroid point 735 can be offset from the ear 726. In some versions,the longitudinal limes 734, and/or the latitudinal lines 736 may includeor be generated from finite element method analysis, and/or a finiteelement method mesh. In other versions, dimensional analysis can beutilized to generate a parametric model for the scanned head 722.

FIG. 8 is an illustration of a scanned head 822, for parametricprocessing 800. After a parametric model has been generated an overlay839 can be generated from the parametric model. The overlay 839 can setthe brow line 838A, the nape line 838B, and/or the linking line 840 fromthe ear 826 of a patient or scanned head 822 to the opposite ear (notshown). The interpolated parametric model or modified parametric modelcan be remapped with an angle variable 841 to a fixed value line orlinking line 840, producing an equally spaced set of lines orsection(s). The spacing of the lines or sections can be calculated tohave the lines spaced with a variation of less than a value provided.The variation value may also be utilized to set the linking line 840,which in at least one version can be set closer to the nape line 838Bthan the brow line 838A. In at least one example, the overlay can alsoinclude forward radial section(s) 842A, 842B, 842C, and/or 842D(collectively 842), and/or rearward radial section(s) 844A, 844B, 844C,and/or 844D (collectively 844). The overlay 839 can also be a remappingof an interpolation of a parametric model. The overlay 839 can then beutilized to generate a design file. The design file could be generatedautomatically, by a computing device, processor, or program, or it maybe semi-automatically generated with some selections made by a doctor orother user. In some examples, the overlay 839 may be calculated and/orgenerated based on the position of the x-axis, and/or symmetry aroundthe x-axis.

FIG. 9A is an illustration of a design file output 951 from a parametricprocessing 900A. The design file output 951, in at least one version,may include a linking section 950, a forward central section 952A, arearward central section 952B, a first set of forward radial section(s)958A, 958B, 958C, and/or 958D (collectively 958), a second set offorward radial section(s) 960A, 960B, 960C, and/or 960D (collectively960), a first set of rearward radial section(s) 956A, 956B, and/or 956C(collectively 956), and a second set of radial section(s) 962A, 962B,and/or 962C (collectively 962). The design file output 951 may begenerated from the interpolated or modified parametric model. A lowergap angle 949, and/or an upper gap angle 947 may be calculated for theforward radial sections, and the rearward radial sections to allow forthe proper divisions and interaction of the individual sections.

The linking section 950 can have a first end 954A and a second end 954Bdistal from one another. In at least one version, the first end 954Awith one side being coupled to the linking section, the radius oppositethat side can be set during one of the processing steps to provide theproper radial angles to allow for an ear cutout. The first end 954A canalso be coupled to a first forward radial section 958A of the first setof forward radial section(s) 958, and/or a first rearward radial section956A of the first set of rearward radial section(s) 956. Similarly, thesecond end 954B with one side being or coupled to the linking section,the radius opposite that side can be set during one of the processingsteps to provide the proper radial angles to allow for an ear cutout.The second end 954B can also be coupled to a first forward radialsection 960A of the second set of forward radial section(s) 960, and/ora first rearward radial section 962A of the second set of rearwardradial section(s) 962.

The first set of forward radial sections 958, the second set of forwardradial sections 960, and the forward central section 952A can be coupledto the linking section 950 through thread, fasteners such as, but notlimited to hook and loop, glues, adhesives, or other similar or likemethods of attachment and/or coupling. Similarly, the first set ofrearward radial sections 956, the second sec of rearward radial sections962, and the rearward central section 952B can be coupled to the linkingsection 950 through thread, fasteners such as, but not limited to hookand loop, glues, adhesives, or other similar or like methods ofattachment and/or coupling.

FIG. 9B is an illustration of a design file output 951 from a parametricprocessing 900A, placed on the head of a patient 922. The design fileoutput 951 can also be exported to a printer, stamper, 3D printer,fabric, sewing, heat or frequency welding, and/or other methods orprocesses for manufacturing or creating a scalp cap. The linking section950 can couple the set of forward radial section(s) 960A, 960B, 960C,and/or 960D (collectively 960), and the set of rearward radialsection(s) 962A, 962B, and/or 962C (collectively 962). An end 954B ofthe linking section 950 allows for the first forward radial section960D, and the first rearward radial section 962A to properly allow for acutout around the ear 926 of a patient 922. The radial section(s)960/962 can mate together, or with the linking section 950, to provide aunique and/or personalized fit for each patient 922. In at least oneversion, each radial section 960/962, central section(s) 952, andlinking section 950 may have a cooling channel that passes through it.The cooling channel(s) may be for each individual section with eachsection having its own input and output, while in other embodimentsthere may be one single channel with a portion of the channel dedicatedto each section. In at least one example, the fluid would flow from theentrance on a right rear side through channels on the rear right side ofthe scalp cap, and then through channels on the right side of the scalpcap and then through channels on the top of the scalp cap, and thenthrough channels on the left side of the scalp cap, and then throughchannels on the left rear of the scalp cap before exiting at the exit onthe left hand side of the rear of the scalp cap.

FIG. 9C is an illustration of a scalp cap 905 as generated from theparametric processing. The scalp cap 905, can have at least one coolingchannel (collectively 951) illustrated as a cooling channel input 951A,and a cooling channel output 951B. The cooling channel(s) 951 allow fora cooling fluid 953 to be flowed and/or pumped through the scalp cap905. The rearward radial section(s) 956A, 956B, and/or 956C(collectively 956), forward radial section(s) 958A, 958B, and/or 958C(collectively 958), forward central section 952A, and rearward centralsection 952B can each have their own individual cooling channels thatcan intersect and/or couple to the previous section or be fluidlycoupled to the cooling channel input and/or output 951. The section(s)952, 956, and/or 958 may each individually be separated by a cut orseparation channel 955 that allows each individual section to increasein closeness to the scalp. The cut or separation channel 955 can be thepoints or sections along the scalp cap 905, where the section(s) areseparated, include but not limited to, a separation such as thatillustrated by the upper gap angle 947 of FIG. 9A. A central linkingchannel 950 can allow the forward and rearward section(s) to beseparately aligned and conforming to the patient's scalp and/or head.The scalp cap 905 allows for a temperature difference between the scalpand the scalp cap 905 to be less than sixteen (16) degrees centigrade.Ideally, a temperature difference of zero degrees is the best result.The fluid pumped through the scalp cap 905, would generally have atemperature range of 0-5 degrees Centigrade. The pressure of the fluidin at least one embodiment would be approximately 0.20 bars or lower,and the rate of flow can be 1.5 liters per minute or less.

FIG. 10 is an illustration of an alternative design output 1070 from aparametric process 1000. The design output 1070 can include a forwardcentral section 1072A, and a rearward central section 1072B. The centralsections 1072, in at least one example are pointed or arrowhead shapedto allow for the angling of the remaining sections to provide a properfit. The first forward petal 1074 can have two offshoots 1076A and1076B. Similarly, the second forward petal 1090 can have a firstoffshoot 1092A and second offshoot 1092B. The rear section petals 1080and 1084 each have two offshoots 1082A, 1082B, and 1086A, 1086B. Theside petals 1078 and 1088 each have a notch 1079/1089 to allow for thedesign output 1070 to conform around a patient's ear.

FIG. 11 is an illustration of a cooling system 1100. The cooling system1100 can include a scalp cap 1105, a thermal cap 1106, a securing cap1108, a cooling channel 1195/1196, and a cooling device 1193 that mayhave an input 1197 and/or an output 1198. The cooling device 1193, maybe coupled to a computing device configured to generate control signals,and/or evaluate or analyze the effects of the cooling system 1100. In atleast one version, a patient or the provider (not illustrated) can placeeach of the cap(s) 1105, 1106, and/or 1108 onto the head allowing acooling channel 1165/1166 to be coupled from the scalp cap 1105 to thecooling device 1193. A cooling fluid can traverse the cooling channel1195/1196, and/or channels throughout the scalp cap 1105 to provide acooling effect to the scalp and/or hairline of a patient (notillustrated). The cooling fluid can include water, and other fluid 1194capable of transferring a temperature difference. A cooling fluid may bepassed from the cooling device that operates to cool the temperature ofthe fluid, while maintaining the fluid above 0 degrees Centigrade orfreezing. The cooling device can operate with an alcohol based fluid,that can be pumped by at least one fluid pump. The fluid pump may alsobe coupled to sensors, such as temperature sensors, that can triggeroperational changes of the pump or the fluid cooling mechanisms of thecooling device. The cooling device in at least one embodiment may be aC3 Dignicap.

The present disclosure may also include a computing device that caninclude any of an application specific integrated circuit (ASIC), amicroprocessor, a microcontroller, a digital signal processor (DSP), afield-programmable gate array (FPGA), or equivalent discrete orintegrated logic circuitry. In some examples, the system may includemultiple components, such as any combination of one or moremicroprocessors, one or more microcontrollers, one or more DSPs, one ormore ASICs, or one or more FPGAs. It would also be understood thatmultiples of the circuits, processors, or controllers could be used incombination or in tandem, or multithreading.

The components of the present disclosure may include any discrete and/orintegrated electronic circuit components that implement analog and/ordigital circuits capable of producing the functions attributed to themodules herein. For example, the components may include analog circuits,e.g., amplification circuits, filtering circuits, and/or other signalconditioning circuits. The components may also include digital circuits,e.g., combinational, or sequential logic circuits, memory devices, etc.Furthermore, the modules may include memory that may includecomputer-readable instructions that, when executed cause the modules toperform various functions attributed to the modules herein.

Memory may include any volatile, non-volatile, magnetic, or electricalmedia, such as a random-access memory (RAM), dynamic random accessmemory (DRAM), static random access memory (SRAM), read-only memory(ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM(EEPROM), flash memory, hard disks, or any other digital media.Additionally, there may also be a tangible non-transitory computerreadable medium that contains machine instructions, such as, a (portableor internally installed) hard drive disc, a flash drive, a compact disc,a DVD, a zip drive, a floppy disc, optical medium, magnetic medium, orany other number of possible drives or discs, that are executed by theinternal logic of a computing device. It would be understood that thetangible non-transitory computer readable medium could also beconsidered a form of memory or storage media.

FIG. 12 is an illustration of a method of manufacture for a scalpcovering 1200. A scalp cap or covering (not illustrated) can be preparedfrom a scanning procedure that includes the use of systems or devicessuch as, but not limited to, 3D scanning, X-Ray, CAT scan, MIR, or otherimaging systems or devices for scanning a patient's scalp to generate ascan data set 1201. The data acquired from the scanning can be utilizedas a scan data set by a program (or a program executed from a computerrelated medium), processor, or computing device. In at least oneversion, the scan data set can be imported by a computing device,processor, or program 1202. The importing step can also include theconversion of the scan data set from a first file format, to a secondfile format. In some examples, a rendering of the scan data set may beperformed during the importation step. The rendering may include atleast one axis to provide a contextual or dimensional reference for therendered data.

The creating a parametric model from the scan data set step 1203, in atleast one version, includes determining criteria for each individualpatient, the centroid point on a patient's head, the minimum azimuthalangle along the nape of a patient, the maximum azimuthal angle at theforehead of a patient, and the radius in angle around the ear of thepatient. In some examples, one of the criteria is selected manuallyallowing the remaining necessary criteria to be calculated, while inother examples all the criteria can be calculated by a computing device,processor, or program. A parametric model can then be created from thedetermined or calculated criteria, and the scan data set.

The parametric model can then be interpolated 1204. The interpolatingthe parametric model step can also include interpolating the radialdimensions of a patient's head, interpolating at least one surface pointof a patient's head, interpolating the normal vector of a patient'shead, interpolating a cross-line distance for a specific set of pointson a patient's head, interpolating a distance forward from the napealong a constant angle from a specified set of points on a patient'shead, interpolating an azimuthal angle halfway between the nape andforehead of a patient. These interpolations and calculation can bestored as part of the parametric model, or a modified parametric model.

A remapping of the parametric or modified parametric model 1205 canallow for the parametric model or modified parametric model to bedivided into a forward section, a rearward section, and a linkingsection. The remapping allows for angles calculated and/or generated aspart of the parametric or modified parametric model may be utilized togenerate fixed angles, and/or fixed lines or distances. The fixedangles, and/or fixed lines or distances can then be utilized to dividespecific portions of the scanned head of a patient into fixed sections.The sections can have any number of shapes and/or sizes, based on thedimensions of the scanned head of a patient. The shapes and/or sizes canbe based on ratios, minimum, and/or maximum dimensions that allow theremapped parametric model to be within certain design specifications,that may be preprogramed or specified during the remapping step toreduce the variation.

The remapped parametric file can then be utilized to generate a designfile 1206. The design file can be generated to reduce the number offorward and rearward sections. The number of sections can be based on avariation value, and/or the azimuthal angle(s) of the individualsections. In at least one version, the linking section that couples theforward and rearward sections can be generated at a position close tothe nape line than the brow line. In other versions, the linking sectionposition may be generated based on a symmetry above and/or below thex-axis of the scanned patient head. The sections may also include aforward and/or rearward gap(s) that can be on the number of individualsection(s) and/or the angles utilized in the design file.

The design file may also include a polyhedral segmented surface createdfrom a function utilizing a forward or reward flag, the individualsection flag, the individual section angle flag, and/or the positionflag. In at least one version, the flags could also include a set ofvalues. The design file can then be output as a data file or be sentdirectly to a manufacturing system or device. The design data file couldoutput 1207 in any number of data formats, including but not limited to,JPG, PNG, TIFF, STL, CAD, CSV, XLSX, or other similar data formats.

FIG. 13 is an illustration of a method of use for a scalp coveringsystem 1300. A patient may place an inner scalp covering over theirscalp 1301. The inner scalp covering may also be fluidly coupled to acooling device or system through a cooling channel. The inner scalpcovering device may then be covered with an intermediate scalp covering1302. The intermediate scalp covering can also include thermallyresistive materials to assist in maintaining a cooling effect along thescalp of a patient. An outer scalp covering can be interfaced with theintermediate scalp covering and the inner scalp cover 1303. The outerscalp covering can have at least one securing mechanism. A securing ofthe outer scalp covering to the patient's scalp can occur by utilizingat least two securing mechanisms coupled to the outer scalp covering1304. A patient may also wet their hair to provide a better fit and/orcooling effect for the cooling device and/or system.

While this disclosure has been particularly shown and described withreference to preferred embodiments, it will be understood by thoseskilled in the art that various changes in form and detail may be madetherein without departing from the spirit and scope of the invention.The inventors expect skilled artisans to employ such variations asappropriate, and the inventors intend the invention to be practicedotherwise than as specifically described herein. Accordingly, thisdisclosure includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the disclosure unlessotherwise indicated herein or otherwise clearly contradicted by context.

While various embodiments in accordance with the principles disclosedherein have been described above, they have been presented by way ofexample only, and not limitation. Thus, the breadth and scope of thisdisclosure should not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with any claimsand their equivalents issuing from this disclosure. Furthermore, theabove advantages and features are provided in described embodiments, butshall not limit the application of such issued claims to processes andstructures accomplishing any or all the above advantages.

Additionally, the section headings herein are provided for consistencywith the suggestions under 37 C.F.R. 1.77 or otherwise to provideorganizational cues. These headings shall not limit or characterize theinvention(s) set out in any claims that may issue from this disclosure.Specifically, and by way of example, although the headings refer to a“Technical Field,” the claims should not be limited by the languagechosen under this heading to describe the so-called field. Further, adescription of a technology as background information is not to beconstrued as an admission that certain technology is prior art to anyembodiment(s) in this disclosure. Neither is the “Brief Summary” to beconsidered as a characterization of the embodiment(s) set forth inissued claims. Furthermore, any reference in this disclosure to“invention” in the singular should not be used to argue that there isonly a single point of novelty in this disclosure. Multiple embodimentsmay be set forth according to the limitations of the multiple claimsissuing from this disclosure, and such claims accordingly define theembodiment(s), and their equivalents, that are protected thereby. In allinstances, the scope of such claims shall be considered on their ownmerits in light of this disclosure, but should not be constrained by theheadings set forth herein.

We claim:
 1. An apparatus for a scalp covering comprising: a linkingsection having a first end and a second end; a forward central sectioncoupled to the linking section at a first forward central section end; arearward central section coupled to the linking section at a firstrearward central section end; a set of forward left radial sectionscoupled to the linking section wherein the set of forward left radialsections comprises at least two forward left radial sections that areeach progressively further in distance from the forward central sectionwherein each of the at least two forward left radial sections aremovable with respect to an adjacent forward left radial section; a setof forward right radial sections coupled to the linking section whereinthe set of forward right radial sections comprises at least two forwardright radial sections that are each progressively further in distancefrom the forward central section wherein each of the at least twoforward right radial sections are movable with respect to an adjacentforward right radial section; a set of rearward left radial sectionscoupled to the linking section wherein the set of rearward left radialsections comprises at least two rearward left radial sections that areeach progressively further in distance from the rearward central sectionwherein each of the at least two rearward left radial sections aremovable with respect to an adjacent rearward left radial section; and aset of rearward right radial sections coupled to the linking sectionwherein the set of rearward right radial sections comprises at least tworearward right radial sections that are each progressively further indistance from the rearward central section wherein each of the at leasttwo rearward right radial sections are movable with respect to anadjacent rearward right radial section.
 2. The apparatus of claim 1,wherein the linking section is manufactured of a thermally conductivematerial.
 3. The apparatus of claim 1, wherein the forward centralsection or the rearward central section is manufactured of a thermallyconductive material.
 4. The apparatus of claim 1, wherein the radialsections are manufactured of a thermally conductive material.
 5. Theapparatus of claim 1, further comprising a first set of tubular membersfor circulation of a cooling fluid through the scalp covering.
 6. Theapparatus of claim 5, wherein a plurality of the sections each comprisea portion of the first set of tubular members.
 7. The apparatus of claim6, wherein the portion of the first set of tubular members extends fromthe linking section along a length of one of the plurality of sectionsand back to the linking section.
 8. The apparatus of claim 5, whereinthe first set of tubular members are fluidly connected to a coolingdevice.
 9. The apparatus of claim 1, wherein each of the forward leftradial sections and the forward right radial sections are coupledperpendicularly to the linking section and substantially parallel to theforward central section.
 10. The apparatus of claim 1, wherein each ofthe rearward left radial sections and the rearward right radial sectionsare coupled perpendicularly to the linking section and substantiallyparallel to the rearward central section.
 11. A system for scalpcovering comprising: an inner scalp covering, wherein the inner scalpcovering further comprises a linking section having a first end and asecond end, a forward central section coupled to the linking section ata first forward central section end, a rearward central section coupledto the linking section at a first rearward central section end, a set offorward left radial sections coupled to the linking section wherein theset of forward left radial sections comprises at least two forward leftradial sections that are each progressively further in distance from theforward central section wherein each of the at least two forward leftradial sections are movable with respect to an adjacent forward leftradial section; a set of forward right radial sections coupled to thelinking section wherein the set of forward right radial sectionscomprises at least two forward right radial sections that are eachprogressively further in distance from the forward central sectionwherein each of the at least two forward right radial sections aremovable with respect to an adjacent forward right radial section; a setof rearward left radial sections coupled to the linking section whereinthe set of rearward left radial sections comprises at least two rearwardleft radial sections that are each progressively further in distancefrom the rearward central section wherein each of the at least tworearward left radial sections are movable with respect to an adjacentrearward left radial section; and a set of rearward right radialsections coupled to the linking section wherein the set of rearwardright radial sections comprises at least two rearward right radialsections that are each progressively further in distance from therearward central section wherein each of the at least two rearward rightradial sections are movable with respect to an adjacent rearward rightradial section; an intermediate scalp covering; and an outer scalpcovering.
 12. The system of claim 11, wherein the inner scalp coveringis constructed of a thermally conductive material.
 13. The system ofclaim 11, wherein the intermediate scalp covering is constructed of athermally non-conductive material.
 14. The system of claim 11, whereinthe outer scalp covering is constructed of a thermally resistantmaterial.
 15. The system of claim 11, wherein the inner scalp coveringis fluidly coupled to a cooling device.
 16. The system of claim 11,wherein the outer scalp covering further comprises a first securingmechanism, and a second securing mechanism.
 17. The system of claim 16,wherein the outer scalp covering is secured against a patient's scalpvia the first securing mechanism and the second securing mechanism. 18.The system of claim 17, wherein the outer scalp covering can bedynamically adjusted using the first and second securing mechanisms topress the inner scalp covering to a patent's scalp.
 19. The system ofclaim 11, wherein the inner scalp covering is further comprises aplurality of the sections each comprise a portion of a first set oftubular members.
 20. The system of claim 19, wherein the tubular membersare coupled fluidly to a cooling device.